510(k) K902193

KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP by Kevtek Medical Products, Inc. — Product Code BTR

K902193 is an FDA 510(k) premarket notification submitted by Kevtek Medical Products, Inc. for the device "KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP". The FDA issued a decision of Substantially Equivalent on March 15, 1991. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Kevtek Medical Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1991
Date Received
May 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type